Posted to MedZilla on 5/26/2018


inVentiv Health

Sr. Regulatory Consultant 69468-MZ


 
 

City Raleigh
State North Carolina [NC]
Title Sr. Regulatory Consultant
Job ID 69468
Overview You re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn t cut it you ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you re known for your good nature. You ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.
Responsibilities

In this role, you will provide strategic regulatory and technical support for assigned product development projects, including preparing and/or supervising product development documents and regulatory agency submissions, overseeing project regulatory activities, and supporting clients and project teams. You will:

  • Conduct research and provide critical regulatory evaluation of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses or product development plans.
  • Supervise the preparation of administrative and technical components of regulatory agency submissions for the conduct of clinical trials, for product registration, and for post-approval maintenance, in electronic common technical document (eCTD) format.
  • Design and prepare briefing packages for regulatory agency meetings or advice and lead these agency interactions.
  • Lead the delivery of day-to-day regulatory activities for assigned projects according to agreed timelines, budgets, and strategies.
  • Represent regulatory on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.
  • Prepare estimates for conducting regulatory services as part of single or multiple service proposals.
  • Meet independently with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.
  • Ensure compliance with appropriate global regulatory requirements and Syneos Health policies and processes.
  • Design training materials and share best practices in the regulatory area, both internally and externally.
  • Represent regulatory in internal or external project audits.
  • Represent regulatory on internal cross-functional initiatives.
Requirements

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

  • A Bachelor s Degree or PhD (preferred), preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
  • Moderate pharmaceutical/medical device related experience.
  • More than 3 years experience in regulatory affairs, including experience in managing regulatory projects.
  • Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, CTA, MAA, and CTD, including electronic submissions.
  • Experience working in an independent office environment, and in a complex multi-process oriented environment in general preferred.
  • Excellent customer service and interpersonal skills, with the ability to work both as a team member and independently. Excellent written and verbal communication skills. Good quality management skills. Problem-solving and decision-making skills. Ability to interact with staff from multiple departments and offices to establish project standards.
  • The ability to travel up to 25%
  • The drive for self-development, the ability to collaborate, and an action-oriented work ethic

Full Syneos Health benefits which include

  • Competitive compensation

  • Generous paid time off and company paid holidays
  • Comprehensive medical, dental, and vision package
  • Matching 401K
  • Dedicated training and support
  • Referral bonuses and other personalized quality of life conveniences
Make your work matter everywhere. Be a driving force in a rapidly evolving healthcare industry.
Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Vets/Disabled)
Position Type/Category Compliance/Regulatory
Recruiting Area Corporate Direct
Employment/Job Type Full Time
Employment Type Syneos Health position

Please visit our website at commercialcareers.inventivhealth.com

 
 


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